NCT01344863已完成1 期
A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 119
- 主要终点
- Area under plasma concentration curve of trastuzumab
研究概览
简要总结
This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male patients, 18 to 45 years of age, inclusive
- •No history of hypersensitivity or allergic reactions following drug administration
- •No history of clinically significant or clinically relevant cardiac condition
- •No history of previous anticancer treatment
- •Body mass index (BMI) between 18-32 kg/m2, inclusive
排除标准
- •Positive test result for drugs of abuse
- •Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2
- •Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood pressure greater than 90 mmHG or less than 50 mmHG
- •Clinically significant abnormal laboratory values
研究组 & 干预措施
1
Experimental
干预措施: trastuzumab [Herceptin] (Drug)
2
Active Comparator
干预措施: trastuzumab [Herceptin] (Drug)
结局指标
主要结局
Area under plasma concentration curve of trastuzumab
时间窗: 21 days
Maximum observed plasma concentration of trastuzumab
时间窗: 21 days
次要结局
- Plasma concentration of trastuzumab(Day 21)
- Safety: Incidence of adverse events(21 weeks)
研究者
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